BioXcel Therapeutics Inc. (BTAI) has a clinical trial catalyst to watch this month, related to its lead drug, IGALMI, in an expanded indication.
IGALMI, also known as BXCL501, administered under the supervision of a health care provider, is approved by the FDA for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults in two dosage strengths of 120 mcg and 180 mcg, depending on the severity of the patient's agitation.
In the second quarter of 2025, the net product revenue of IGALMI slumped to $120 thousand from $1.1 million for the same period in 2024.
A phase III trial evaluating the safety of a 120-mcg dose of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting, dubbed SERENITY At-Home, is underway. The trial is fully enrolled with over 205 patients, and top-line results from the study are expected this month (August).
The company ended June 30, 2025, with cash, cash equivalents, and restricted cash of $18.6 million.
When we alerted readers to BTAI on July 1, 2025, it was trading at $1.90. The stock saw a modest rise to $2.27 by mid-month, before entering a steady decline, reaching a low of $1.30 by the end of July. However, the bearish sentiment began to shift in early August. The stock touched a high of $8.08 on August 12, 2025, before giving back some of its gains and closing Friday's (Aug.15, 2025) session at $5.48.
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